Principal Scientist​/Senior Principal Scientist

Join an international team of experts and play a key role in advancing the safe development of innovative medicines. In this position, you will contribute to the assessment of mutagenic risks, support global development projects throughout the product lifecycle, and influence critical development and regulatory decisions through your scientific expertise.

This position can be filled either as Principal Scientist or Senior Principal Scientist.

Join an international team of experts and play a key role in advancing the safe development of innovative medicines. In this position, you will contribute to the assessment of mutagenic risks, support global development projects throughout the product lifecycle, and influence critical development and regulatory decisions through your scientific expertise.

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This position can be filled either as Principal Scientist or Senior Principal Scientist.

• Your primary responsibilities will include coordinating, evaluating, and conducting in silico assessments to predict mutagenicity in accordance with ICH M7, including the scientific evaluation of related literature searches
• In close collaboration with i internal and external stakeholders, you will develop and support derisking strategies for mutagenic impurities and metabolites across different stages of project development
• Furthermore, you will prepare scientific reports, including expert judgment on the relevance of findings, and contribute to regulatory submission documents
• As a subject matter expert, you will advise Research & Development teams on mutagenic impurities, mutagenic metabolites, and acceptable exposure limits for mutagenic carcinogens
• In addition, you will represent scientific results and recommendations in international project teams, discuss their implications, and support informed risk-based decision-making
• You will also independently manage and respond to health authority inquiries related to ICH M7 topics, coordinate global project requirements, and ensure compliance with regulatory expectations and internal procedures

Additional tasks for the Senior Principal Scientist-Role

• With regard to the global genotoxicity strategy, you will take a leading role in its implementation and further development to ensure the application of avoidance principles and scientifically sound risk assessments
• Moreover, you will lead complex and time-critical issues with significant regulatory impact and provide recommendations to international stakeholders
• Additionally, you will contribute to scientific committees and expert forums, foster scientific exchange, and drive the advancement of scientific standards and best practices

• PhD in Chemistry, Biology, Biochemistry Eor comparable scientific degree with relevant professional experience, or Master's degree in Biology or Computer Science
• Solid knowledge of mutagenicity, structural reactivity, and genetic toxicology
• Expertise in in silico mutagenicity prediction, including relevant software tools, derisking strategies, and associated genetic toxicology assays
• Experience in literature research and the use of scientific databases
• Knowledge of pharmaceutical development and the application of genetic toxicology principles in a drug development environment
• Ability to coordinate multiple stakeholders, work effectively under pressure, and communicate complex scientific findings in German and English

Additional requirements for the Senior Principal Scientist-Role

• Extensive experience in applying and interpreting in silico mutagenicity assessments within pharmaceutical development
• Demonstrated capability to lead complex scientific topics and coordinate cross-functional global stakeholders
• Experience in…